Collagen products used in medical devices
Because of its many appealing characteristics, collagen has a long history of use in medical devices ranging from hemostats and surgical meshes to bone void fillers. The material is ideal because, when purified properly, it is biocompatible, can be provided in a variety of shapes and sizes, and acts as a temporary scaffold for tissue regeneration.
Collagen processing technology
DSM produces medical devices from various collagen formulations. These materials are manufactured from purified collagen extracts derived from bovine dermis, which is a source of primarily Type I Collagen. The difference between DSM's formulations is the degree to which the collagen fibers are dissociated. Collagen fibers are ordered bundles of collagen fibrils, which, in turn, are ordered as bundles of collagen molecules (tropocollagen). With our purified collagen processing technology we can process collagen in fiber, fibril and soluble collagen forms. From raw materials to devices, our slurry and solution processing allows us to make products with custom-tailored properties for your application.
Our collagen processing allows us to provide products in many different forms including sheets, putties, injectables, gels, three dimensional shapes, coatings, fibers or powders to create resorbable medical devices. With these novel processing methods, we can produce custom architectures to meet the specific performance characteristics of end-use products.
Collagen blending and compounding
To further enhance the customization of your product, we have the ability to blend additives into the collagen forms. We have experience compounding many different active ingredients including:
- Beta-tricalcium phosphate
- Anorganic bone
- Calcium sulfate
- Bioactive glass
- Synthetic polymers
- Hylauronic acid
Control of mechanical properties
In medical applications where higher strength or longer in-vivo persistence is required, DSM’s proprietary methods for orienting the fibers in the collagen impart greater strength. We can alter the physical and chemical properties by adding chemical or non-chemical crosslinking. We can optimize these methods of formulation to provide the best material properties for your application.
In addition to taking measures to ensure that the starting materials are disease free, DSM has controls in place to ensure that the materials remain safe throughout various manufacturing processes. Our manufacturing facility is ISO 13485 certified and our collagen is processed in certified ISO Class 8 cleanrooms. With routine audits and testing, we ensure the material always meets government and customer specifications.
Potential end-use applications
DSM’s collagen configurations have the potential to be used in a variety of clinical applications, ranging from bone void fillers and cartilage repair devices, wound dressings and hemostatic agents, to nerve regeneration conduits and tissue augmentation supports.